1. Field of the Invention
The present invention generally relates to a connector device for connecting a first and a second fluid container. More particularly, the present invention relates to a vial connector assembly with an integral polymeric spike for penetrating a vial stopper and accessing the medicament within a vial.
2. Description of Related Art
A vial connector assembly is provided to connect a vial to a fluid container to enable the transfer of medicament between the vial and fluid connector.
For instance, a vial connector assembly is typically provided to enable the transfer of liquid medicament from a vial to a fluid container by means of an injector needle, or to enable the transfer of a dissolving solvent from a fluid container to a vial storing a dry medicament. The same vial connector assembly may also be used to attach a vial to an intravenous fitting to deliver medicament directly from the vial to a patient.
A vial connector assembly typically includes a fluid transfer device, such as a needle or spike that penetrates an elastomeric stopper or membrane sealing the opening of the vial. The fluid transfer device thus provides a means for transferring medicament from the vial to a fluid container, a means for introducing solvent into the vial, and a means for delivering medicament out of the vial.
Contemporary vial connector assemblies, however, fail to address two issues related to the transfer of medicament between a vial and a fluid container.
First, there is a potential for hazardous aerosols, particles, and vapors to leak into the environment in contemporary vial assemblies when transferring liquid medicament from a vial with an injection needle. Consequently, a user may be exposed to hazardous substances consisting of cytotoxic drugs, radio-labeled or allergy-inducing substances that may contaminate the user through inhalation or condensation on the skin of a user. Some medicaments are even known to penetrate protection gloves and thereby contaminate the user. Exposure to contaminations like this may, on a long term basis, give rise to alarmingly high concentrations of medicaments in the blood of the user.
Second, there is a potential for coring when the elastomeric stoppers of vials are pierced by a fluid transfer device, such as a sharp, metal cannulated needle, of contemporary vial connector assemblies. Coring occurs as an integral vial connector spike or an injection needle is urged through the stopper and the spike or injection needle punches or cuts a small particle of rubber from the stopper. This stopper fragment either drops into the vial or becomes lodged in the cannula and is possibly withdrawn into the syringe. In either case, the sterility of the vial contents is compromised and, in the latter case, injection of particulate matter into the patient may occur.
Contemporary devices for the aforementioned transfer of medicaments typically use a hollow pointed spike or needle for piercing an elastomeric vial stopper. Coring results from the vial connector spike or injection needle cutting a core of stopper material with the relatively sharp edges found at an intersection of an inside diameter of the spike or needle and a surface at the end of the spike or needle. These cores represent a potential health hazard if they pass along with the liquid medication into the patient's body. Also, if the cores are large enough or if there are many of them, the stopper may not retain enough material to effectively seal the vial in order to prevent leakage or to protect sterility. In addition, if the device used to puncture the stopper is too large, it may damage the stopper, even in the absence of any coring, by ripping or tearing the stopper so that it no longer effectively seals the vial.
Additionally, in many applications, the vial contents are repeatedly accessed. For instance, many injectable medicaments are packaged in multidose vials requiring vial access for the withdrawal of each unit dose. Also, many pharmaceuticals are lypholysed in sterile vials for prolonged stability. Such packaging also requires multiple vial entries to reconstitute the contents and withdrawal of the reconstituted contents. The tearing and abrasion caused by multiple vial accesses by a sharp injector needle results in pepper-like fragments contaminating the vial contents.
For the reasons stated above, there is a need for a vial connector assembly that connects a vial to a fluid container while safely enabling the transfer of medicament between the vial and fluid container while avoiding leakage or air contamination imparted by the injection needle during the transfer.
Additionally, there is a need for non-coring spike assembly that allows the transfer of medicament to and from a vial with a pierceable stopper while incurring minimal stopper damage and requiring minimal penetration forces.